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Translation of e a-t 7/2022c


Nirmatrelvir plus Ritonavir (PAXLOVID) in the management of SARS-CoV-2 - without risk factors, no benefits evident

The protease inhibitor combination of nirmatrelvir plus ritonavir (PAXLOVID) was granted conditional approval for the treatment of adult COVID-19 patients with an increased risk of a severe clinical course. If treatment is started within five days of the onset of symptoms, it reduces the frequency of COVID-19-related hospitalisation or death within 28 days from 6.3% to 0.8% (relative risk reduction 88%; see a-t 2022; 53: 35 etc.). However, according to a press release by the supplier, Pfizer (1), no benefit can be confirmed with the combination in individuals without risk factors. In an interim analysis of the EPIC-SR study (2), COVID-19-related hospital admissions or death – the most important secondary endpoint in this respect – were only reduced numerically and relatively by 51%, from 1.8% (10/569) under placebo to 0.9% (5/576) under nirmatrelvir plus ritonavir. Similarly, no significant effect was established with regard to the primary endpoint, namely the sustained relief of all disease symptoms for four consecutive days. Recruitment for the study has meanwhile been discontinued (1), –Ed.

1Pfizer: Press release dated 14 June 2022; https://a-turl.de/mazy
2Pfizer: ClinicalTrials.gov, dated 13 Apr. 2022; https://a-turl.de/zka5

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